Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260676
Status:
UNKNOWN
Last Update Posted:
2009-06-17
First Post:
2005-11-29
Brief Title:
Protective Ventilatory Strategy in Potential Organ Donors
Sponsor:
University of Turin Italy
Organization:
University of Turin Italy
Study Overview
Official Title:
a Randomised Control Trial on Protective Ventilatory Strategy in Potential Organ Donors
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to verify if a PROTECTIVE ventilatory strategy low tidal volume and high PEEP application of CPAP during the apnea test and recruitment maneuvers improves lung function and increases the number of lungs eligible for transplantation
Detailed Description:
Lung transplantation reduces mortality in patients with severe pulmonary diseases While 50-70 of kidney liver and heart are eligible for transplantation only 20 of the lungs fit the criteria for transplant More than 30 of the lungs theoretically suitable for donation are not actually collected because following brain death they develop severe hypoxemia and abnormal chest X-ray Guidelines for critical care management of potential organ donors suggest that after the diagnosis of brain death treatment priority can be shifted from cerebral protection to a strategy aimed at preserving solid organ perfusion and function However the ventilatory strategy recommended for potential lung donors is similar to the one proposed for brain injured patients This ventilatory strategy based on high Vt and low PEEP may induce a further exacerbation of the pulmonary and systemic inflammatory response in patients with acute lung injuryacute respiratory distress syndrome Moreover recent data suggest that this strategy may be harmful in normal lungs of mechanical ventilated patients Aim of the study is to verify if a PROTECTIVE ventilatory strategy low tidal volume and high PEEP application of CPAP during the apnea test and recruitment maneuvers improves lung function Primary end point of the study is to increase the number of lungs that meet the eligibility criteria for transplantation Secondary end point is to increase the number of lungs really transplanted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None